2026-04-17T04:09:43Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/129102025-10-24T10:38:58Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Michel-Behnke, Ina
author
Müller, Matthias
author
Stiller, Brigitte
author
Kriebel, Thomas
author
Kanaan, Majed
author
Környei, László
author
Roses-Noguer, Ferran
2025-10-24T10:38:58Z
2025-10-24T10:38:58Z
2025-04-08T09:01:13Z2025-04-08T09:01:13Z2025-02
http://hdl.handle.net/11351/12910
Heart rate; Paediatrics; Supraventricular tachycardiaFrecuencia cardíaca; Pediatría; Taquicardia supraventricularFreqüència cardíaca; Pediatria; Taquicàrdia supraventricularAims
Landiolol, an ultra-fast acting super-selective beta-blocker, was investigated for the first time in Europe in a prospective clinical study for the management of supraventricular tachycardia (SVT) among paediatric patients.
Methods and results
The LANDI-PED study was a prospective, multicentre, open-label, uncontrolled phase III study aiming to investigate the efficacy, safety, and pharmacokinetics (PK) of landiolol in paediatric patients. Sixty patients in surgical and non-surgical settings aged ≥1 day to <18 years with SVTs of various aetiologies received landiolol as a continuous intravenous infusion starting with 5 μg/kg/min titrated up to 40 μg/kg/min depending on heart rate (HR) reduction for up to a maximum of 24 h. The primary endpoint was restoration of normal sinus rhythm (NSR) within 210 min of infusion start. The primary endpoint was achieved in 15 (25.0%) patients. A total of 24 (40.0%) patients achieved a HR reduction of at least 20% within 210 min of landiolol infusion. A significant HR reduction was observed within minutes post-infusion, with a mean (±SD) reduction after 210 min of −13.2 (±11.5)% (P < 0.0001) in the overall population. By infusion end, 51.7% of patients achieved HR reduction of at least 20% from baseline and/or NSR conversion. The PK characteristics were consistent with the known profile of landiolol among adults. The most common adverse drug reaction was hypotension (10%).
Conclusion
Landiolol is effective and safe in the treatment of SVTs in the paediatric population as demonstrated by reduction of HR and/or restoring NSR. Landiolol was well tolerated with no novel safety concerns reported.
Clinical Trial Registration
EU Clinical Trial Register; EudraCT Number: 2015-001129-17.The study was sponsored by the AOP Orphan Pharmaceuticals GmbH.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
Avaluació de resultats (Assistència sanitària)
Infants
Antiarítmics cardíacs - Ús terapèutic
Taquicàrdia - Tractament
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome
DISEASES::Cardiovascular Diseases::Heart Diseases::Arrhythmias, Cardiac::Tachycardia::Tachycardia, Supraventricular
Other subheadings::Other subheadings::Other subheadings::/drug therapy
CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Cardiovascular Agents::Anti-Arrhythmia Agents
Other subheadings::Other subheadings::/therapeutic use
NAMED GROUPS::Persons::Age Groups::Child
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento
ENFERMEDADES::enfermedades cardiovasculares::enfermedades cardíacas::arritmias cardíacas::taquicardia::taquicardia supraventricular
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::fármacos cardiovasculares::antiarrítmicos
Otros calificadores::Otros calificadores::/uso terapéutico
DENOMINACIONES DE GRUPOS::personas::Grupos de Edad::niño
Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED)
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion